Tocilizumab Plus a Short Prednisone Taper for GCA

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT03726749
Phase
PHASE4
Status
Completed

Conditions

  • Giant Cell Arteritis

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Tocilizumab is an interleukin-6 (IL-6) receptor inhibitor
  • Prednisone — DRUG
    Prednisone is an anti-inflammatory medication

Study Details

This is an open-label pilot study of tocilizumab (TCZ) 162 mg weekly administered subcutaneously for 52 weeks in combination with 8 weeks of oral prednisone.

Key Dates

Start date
Nov 28, 2018
Status verified
Nov 2022
Primary completion
Dec 15, 2021
Completion
Dec 29, 2021

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab and prednisone
    1. TCZ 162 mg administered by subcutaneous injection weekly for 52 weeks. 2. Prednisone taper over 8 weeks with a starting dose between 20 and 60 mg.

Primary Outcome Measure

Sustained Remission [ Time Frame: 52 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

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